No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 04961333224685 | KW3115S | FDS | Gastroscope and accessories, flexible/rigid | PENTAX | |||
2 | 04961333224562 | KW2411S | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | PENTAX | |||
3 | 14961333221650 | CS-C11A | PROfILE Single Use Endoscope Cleaning Brush Kits | EOB | Nasopharyngoscope (Flexible Or Rigid) | N/A | ||
4 | 04961333225569 | EB19-J10U | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | ||
5 | 04961333224449 | KW1815S | FDS | Gastroscope and accessories, flexible/rigid | PENTAX | |||
6 | 14961333221612 | CS4010A | PROfILE Single Use Endoscope Cleaning Brush Kits | EOB | Nasopharyngoscope (Flexible Or Rigid) | N/A | ||
7 | 14961333221438 | OF-B205 | PENTAX Medical single use suction control valve | EOB | Nasopharyngoscope (Flexible Or Rigid) | N/A | ||
8 | 04961333251773 | EG17-J10 | PENTAX Medical Video Upper GI Scope EG17-J10 | FDS | Gastroscope and accessories, flexible/rigid | 2 | N/A | |
9 | 04961333251506 | EB19-J10 | PENTAX Medical Video Bronchoscope EB19-J10 (Made in Malaysia) | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | |
10 | 04961333251803 | EB11-J10 | PENTAX Medical Video Bronchoscope EB11-J10 | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | |
11 | 04961333251346 | VNL15-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Made in Malaysia, Ele PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Made in Malaysia, Electronic IFU) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
12 | 04961333251322 | VNL15-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Made in Malaysia) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
13 | 04961333251254 | VNL8-J10 | "PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10 (Made in Malaysia, Ele "PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10 (Made in Malaysia, Electronic IFU) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
14 | 04961333251230 | VNL8-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10 (Made in Malaysia) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
15 | 04961333251179 | VNL11-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Made in Malaysia, Ele PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Made in Malaysia, Electronic IFU) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
16 | 04961333251155 | VNL11-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Made in Malaysia) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
17 | 04961333249015 | EG38-J10UT | PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT (Made in Malaysia) | ODG,ITX | Endoscopic Ultrasound System, Gastroenterology-Urology,Transducer, Ultrasonic, Diagnostic | 2 | N/A | |
18 | 04961333248933 | EG36-J10UR | PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR (Made in Malaysia) | ODG,ITX | Endoscopic Ultrasound System, Gastroenterology-Urology,Transducer, Ultrasonic, Diagnostic | 2 | N/A | |
19 | 04961333248858 | EG34-J10U | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U (Made in Malaysia) | ODG,ITX | Endoscopic Ultrasound System, Gastroenterology-Urology,Transducer, Ultrasonic, Diagnostic | 2 | N/A | |
20 | 04961333248315 | EG29-i10 | Made in Malaysia | FDS | Gastroscope and accessories, flexible/rigid | 2 | N/A | |
21 | 04961333248209 | EC38-i10L | Made in Malaysia | FDF | Colonoscope and accessories, flexible/rigid | 2 | N/A | |
22 | 04961333248179 | EG-2990i | Made in Malaysia | FDS | Gastroscope and accessories, flexible/rigid | 2 | N/A | |
23 | 04961333248148 | EC-3890Li | Made in Malaysia | FDF | Colonoscope and accessories, flexible/rigid | 2 | N/A | |
24 | 04961333248070 | VNL15-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Electronic IFU) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
25 | 04961333248063 | VNL8-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10 (Electronic IFU) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
26 | 04961333248056 | VNL11-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Electronic IFU) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
27 | 04961333247455 | ED34-i10T2 | FDT | duodenoscope and accessories, flexible/rigid | 2 | N/A | ||
28 | 04961333246632 | ED32-i10 | PENTAX Medical Video Duodenoscope ED32-i10 | FDT | duodenoscope and accessories, flexible/rigid | 2 | N/A | |
29 | 04961333245895 | EC34-i10TL | FDF | Colonoscope and accessories, flexible/rigid | 2 | N/A | ||
30 | 04961333245888 | EG34-i10 | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | N/A | ||
31 | 04961333244744 | EPK-3000 | Made in Thailand | PEA | Endoscope, accessories, image post-processing for color enhancement | 2 | DEFINA | |
32 | 04961333239696 | EG34-J10U | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U | ODG,ITX | Endoscopic Ultrasound System, Gastroenterology-Urology,Transducer, Ultrasonic, Diagnostic | 2 | N/A | |
33 | 04961333239597 | EG36-J10UR | PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR | ODG,ITX | Endoscopic Ultrasound System, Gastroenterology-Urology,Transducer, Ultrasonic, Diagnostic | 2 | N/A | |
34 | 04961333239498 | EG38-J10UT | PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT | ODG,ITX | Endoscopic Ultrasound System, Gastroenterology-Urology,Transducer, Ultrasonic, Diagnostic | 2 | N/A | |
35 | 04961333225507 | EB19-J10 | PENTAX Medical Video Bronchoscope EB19-J10 | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | |
36 | 04961333225453 | EB15-J10 | PENTAX Medical Video Bronchoscope EB15-J10 | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | |
37 | 04961333233618 | EPK-i7010 | PEA | Endoscope, accessories, image post-processing for color enhancement | OPTIVISTA | |||
38 | 04961333232918 | EPK-i5500c | PEA | Endoscope, accessories, image post-processing for color enhancement | 2 | IMAGINA | ||
39 | 04961333248711 | EC34-i10cL | Made in Malaysia | FDF | Colonoscope and accessories, flexible/rigid | 2 | IMAGINA | |
40 | 04961333248544 | EC38-i10cL | Made in Malaysia | FDF | Colonoscope and accessories, flexible/rigid | 2 | IMAGINA | |
41 | 04961333248483 | EG29-i10c | Made in Malaysia | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | IMAGINA | |
42 | 04961333247400 | EC38-i10cL | FDF | Colonoscope and accessories, flexible/rigid | 2 | IMAGINA | ||
43 | 04961333247394 | EC34-i10cL | FDF | Colonoscope and accessories, flexible/rigid | 2 | IMAGINA | ||
44 | 04961333247387 | EG29-i10c | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | IMAGINA | ||
45 | 04961333224821 | KA1811S | FBN | Choledochoscope and accessories, flexible/rigid | 2 | PENTAX | ||
46 | 04961333224807 | KH2430S | GCL | ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY | PENTAX | |||
47 | 04961333224784 | KH2422S | GCL | ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY | PENTAX | |||
48 | 04961333224746 | KH2415S | GCL | ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY | PENTAX | |||
49 | 04961333224722 | KH2411S | GCL | ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY | PENTAX | |||
50 | 04961333224708 | KW3122S | FDS | Gastroscope and accessories, flexible/rigid | PENTAX |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00191506008024 | M00542820 | M00542820 | Monitor Mount | Exalt™ | BOSTON SCIENTIFIC CORPORATION |
2 | 00191506007997 | M0054279Z0 | M0054279Z0 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
3 | 00191506007980 | M0054279R0 | M0054279R0 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
4 | 00191506007966 | M0054279H0 | M0054279H0 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
5 | 00191506007959 | M00542790 | M00542790 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
6 | 00191506007942 | M0054278Z0 | M0054278Z0 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
7 | 00191506007935 | M0054278R0 | M0054278R0 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
8 | 00191506007911 | M0054278H0 | M0054278H0 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
9 | 00191506007904 | M00542780 | M00542780 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
10 | 00191506007898 | M0054277Z0 | M0054277Z0 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
11 | 00191506007881 | M0054277R0 | M0054277R0 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
12 | 00191506007867 | M0054277H0 | M0054277H0 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
13 | 00191506007850 | M00542770 | M00542770 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
14 | 00191506007843 | M0054276Z0 | M0054276Z0 | Monitor | EXALT™ | BOSTON SCIENTIFIC CORPORATION |
15 | 00191506007836 | M0054276R0 | M0054276R0 | Monitor | EXALT™ | BOSTON SCIENTIFIC CORPORATION |
16 | 00191506007812 | M0054276H0 | M0054276H0 | Monitor | EXALT™ | BOSTON SCIENTIFIC CORPORATION |
17 | 00191506007805 | M00542760 | M00542760 | Monitor | EXALT™ | BOSTON SCIENTIFIC CORPORATION |
18 | 00191506007485 | M00542750 | M00542750 | Single-Use Bronchoscope | EXALT™ Model B | BOSTON SCIENTIFIC CORPORATION |
19 | 00191506007454 | M00542730 | M00542730 | Single-Use Bronchoscope | EXALT™ Model B | BOSTON SCIENTIFIC CORPORATION |
20 | 00191506007423 | M00542710 | M00542710 | Single-Use Bronchoscope | EXALT™ Model B | BOSTON SCIENTIFIC CORPORATION |
21 | B634SW0121940202000 | Version 2.2.1 | Monarch Software Laptop v2.2.1 | Monarch Software Laptop v2.2.1 | AURIS HEALTH, INC. | |
22 | B634SW0121930202000 | Version 2.2.1 | Monarch Software Cart v2.2.1 | Monarch Software Cart v2.2.1 | AURIS HEALTH, INC. | |
23 | B634SW0121920202000 | Version 2.2.1 | Monarch Software Tower v2.2.1 | Monarch Software Tower v2.2.1 | AURIS HEALTH, INC. | |
24 | B634SW0121900201060 | Version 2.1.6 | Monarch Software Laptop v2.1.6 | Monarch Software Laptop v2.1.6 | AURIS HEALTH, INC. | |
25 | B634SW0121890201060 | Version 2.1.6 | Monarch Software Cart v2.1.6 | Monarch Software Cart v2.1.6 | AURIS HEALTH, INC. | |
26 | B634SW0121880201060 | Version 2.1.6 | Monarch Software Tower v2.1.6 | Monarch Software Tower v2.1.6 | AURIS HEALTH, INC. | |
27 | B634SW0032760201050 | Version 2.1.5 | Monarch™ Software Laptop v2.1.5 | Monarch™ Software Laptop v2.1.5 | AURIS HEALTH, INC. | |
28 | B634SW0032760201040 | Version 2.1.4 | Monarch™ Software Laptop v2.1.4 | Monarch™ Software Laptop v2.1.4 | AURIS HEALTH, INC. | |
29 | B634SW0032760201030 | Version 2.1.3 | Monarch™ Software Laptop v2.1.3 | Monarch™ Software Laptop v2.1.3 | AURIS HEALTH, INC. | |
30 | B634SW0032760201020 | Version 2.1.2 | Monarch™ Software Laptop v2.1.2 | Monarch™ Software Laptop v2.1.2 | AURIS HEALTH, INC. | |
31 | B634SW0032750201050 | Version 2.1.5 | Monarch™ Software Cart v2.1.5 | Monarch™ Software Cart v2.1.5 | AURIS HEALTH, INC. | |
32 | B634SW0032750201040 | Version 2.1.4 | Monarch™ Software Cart v2.1.4 | Monarch™ Software Cart v2.1.4 | AURIS HEALTH, INC. | |
33 | B634SW0032750201030 | Version 2.1.3 | Monarch™ Software Cart v2.1.3 | Monarch™ Software Cart v2.1.3 | AURIS HEALTH, INC. | |
34 | B634SW0032750201020 | Version 2.1.2 | Monarch™ Software Cart v2.1.2 | Monarch™ Software Cart v2.1.2 | AURIS HEALTH, INC. | |
35 | B634SW0032740201050 | Version 2.1.5 | Monarch™ Software Tower v2.1.5 | Monarch™ Software Tower v2.1.5 | AURIS HEALTH, INC. | |
36 | B634SW0032740201040 | Version 2.1.4 | Monarch™ Software Tower v2.1.4 | Monarch™ Software Tower v2.1.4 | AURIS HEALTH, INC. | |
37 | B634SW0032740201030 | Version 2.1.3 | Monarch™ Software Tower v2.1.3 | Monarch™ Software Tower v2.1.3 | AURIS HEALTH, INC. | |
38 | B634SW0032740201020 | Version 2.1.2 | Monarch™ Software Tower v2.1.2 | Monarch™ Software Tower v2.1.2 | AURIS HEALTH, INC. | |
39 | B634MON0007090 | MON-000709 | MON-000709 | Window Field Generator, Connection Cable, Mounting System | Monarch Advanced Imaging Accessory Kit | AURIS HEALTH, INC. |
40 | B634MON0000060 | MON-000006 | The Monarch Bronchoscope enables electro-mechanical articulation and precise con The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.Monarch Bronchscope 2.0/Monarch Platform (P2) | Monarch Bronchscope 2.0/Monarch Platform (P2) | AURIS HEALTH, INC. | |
41 | B634MON000005R0 | MON000005R | MON000005R | The Monarch Platform (Refurbished) enables electro-mechanical articulation and p The Monarch Platform (Refurbished) enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator. | Monarch™ Platform (Refurbished) | AURIS HEALTH, INC. |
42 | B634MON00000501R0 | MON-000005-01R | Monarch Endoscopy Platform (P1) System, Refurbished | Monarch Endoscopy Platform (P1) System, Refurbished | AURIS HEALTH, INC. | |
43 | B634MON000005010 | MON-000005-01 | Monarch Endoscopy Platform (P1) Tower Upgrade | Monarch Endoscopy Platform (P1) Tower Upgrade | AURIS HEALTH, INC. | |
44 | B634MON00000501 | MON-000005-01 | Monarch Endoscopy Platform (P1) Tower Upgrade | Monarch Endoscopy Platform (P1) Tower Upgrade | AURIS HEALTH, INC. | |
45 | B634MON0000050 | MON000005 | MON000005 | The Monarch Platform enables electro-mechanical articulation and precise control The Monarch Platform enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator. | Monarch™ Platform | AURIS HEALTH, INC. |
46 | B634MBR0002180 | MBR-000218 | MBR-000218 | Bronchoscope Fluidics Tubing | Bronchoscope Fluidics Tubing | AURIS HEALTH, INC. |
47 | B634MBR000211A0 | MBR-000211-A | MRB-000211-A | Monarch Bronchoscope | AURIS HEALTH, INC. | |
48 | B634MBR0000200 | MBR-000020 | MBR-000020 | Bronchoscope Sheath Valve | Bronchoscope Sheath Valve | AURIS HEALTH, INC. |
49 | B634MBR0000190 | MBR-000019 | MBR-000019 | Bronchoscope Valve | Bronchoscope Valve | AURIS HEALTH, INC. |
50 | B634MBR0000180 | MBR-000018 | MBR-000018 | Bronchoscope Fluidics Tubing | Bronchoscope Fluidics Tubing | AURIS HEALTH, INC. |